Use the Celerity Incubator to incubate and automatically read STERIS Celerity Biological Indicators for Steam and Vaporized Hydrogen Peroxide sterilization at 55°C - 60°C for a fluorescent result.

Device Description

The Celerity Incubator incubates and reads fluorescent Vaporized Hydrogen Peroxide (VHP) and Steam Biological Indicators (BIs). The BI is incubated at 59° C with an acceptable tolerance of -4°C/+1°C. During incubation, the BI is monitored for a potential fluorescence signal generated as a result of the production of a-glucosidase. When a growth response has been detected or when the required incubation time has elapsed, the incubator indicates the results to the user.

AI/ML Overview

The provided text describes the Celerity Incubator, a Class II medical device, and its performance testing to demonstrate substantial equivalence to a predicate device. This device is designed to incubate and automatically read STERIS Celerity Biological Indicators for sterilization processes.

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

1. Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Result
Software Validation	The software that controls the system was validated and determined to operate effectively and as designed.	Pass
Qualification Testing with intended Biological Indicators	Fluorescent Read meets ≥ 97% alignment with 7-day grow out per FDA guidance on Reduced Incubation Time for intended Celerity 5 HP Biological Indicators and Celerity 20 HP Biological Indicators. (This means that the rapid fluorescent reading of the Celerity Incubator should correctly identify 97% or more of the biological indicators that would show growth after a full 7-day incubation period, as per FDA guidelines for reduced incubation time.)	Pass
Recognition of additional barcodes	Incubator reads barcodes correctly.	Pass

2. Sample Size and Data Provenance

The document does not explicitly state the specific sample sizes used for each test (e.g., how many biological indicators were tested for the Qualification Testing or how many barcodes were tested for recognition).

Data Provenance: The document generally refers to "performance testing" conducted by STERIS Corporation for their 510(k) submission. It does not specify the country of origin of the data or whether it was retrospective or prospective. Given it's a 510(k) submission for a new device, the testing would typically be prospective, conducted under controlled laboratory conditions to demonstrate performance.

3. Number of Experts and Qualifications for Ground Truth

The document does not provide details on the number of experts used or their qualifications for establishing ground truth, as the ground truth appears to be based on physical biological indicator growth ("7-day grow out") rather than expert review of complex images or data.

4. Adjudication Method for the Test Set

Not applicable. The "ground truth" for the biological indicator test is the physical 7-day grow out, which is an objective measure, not a subjective interpretation requiring adjudication among experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. The Celerity Incubator is a device that automates the reading of biological indicators, not an AI system assisting human readers with interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.

6. Standalone Performance (Algorithm Only)

Yes, the testing described appears to be a standalone performance evaluation of the Celerity Incubator's ability to accurately read biological indicators, without human intervention in the reading process itself. The incubator performs the incubation and optical reading automatically.

7. Type of Ground Truth Used

The primary ground truth for the "Qualification Testing with intended Biological Indicators" is 7-day grow out of the biological indicators. This is an objective measure where biological indicators are incubated for a standard 7-day period to definitively determine if microbial growth occurred, which signifies a sterilization failure. The fluorescent reading from the Celerity Incubator is then compared against this established 7-day grow out result. For "Software Validation" and "Recognition of additional barcodes," the ground truth would be based on the intended functional specifications and correct barcode decoding, respectively.

8. Sample Size for the Training Set

Not applicable. This device is an automated incubator and reader, not an AI/ML device that requires a "training set" in the context of machine learning model development. Its function relies on established physical and optical principles for detecting fluorescence, not on learning from a large dataset.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this device in the context of AI/ML.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

February 6, 2025

STERIS Corporation Karly Eitzman Regulatory Affairs Specialist 5960 Heisley Road Mentor, Ohio 44060

Re: K250061

Trade/Device Name: Celerity Incubator Regulation Number: 21 CFR 880.2800 Regulation Name: Sterilization Process Indicator Regulatory Class: Class II Product Code: FRC Dated: January 8, 2025 Received: January 10, 2025

Dear Karly Eitzman:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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Sincerely,

Digitally signed by Stephen A. Anisko -S Stephen A. Anisko -S
Stephen A. Anisko -S Stephen A. Anisko -S
Stephen A. Anisko -S Date: 2025.02.06 17:3 Date: 2025.02.06 17:39:07 -05'00'

for: Christopher K. Dugard Division Director DHT4C: Division of Infection Control Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K250061

Device Name

Celerity Incubator

Indications for Use (Describe)

Use the Celerity Incubate and automatically read STERIS Celerity Biological Indicators for Steam and Vaporized Hydrogen Peroxide sterilization at 55°C-60°C for a fluorescent result.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary For Celerity Incubator

STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198

Mrs. Karly Eitzman Contact: Regulatory Affairs Specialist Tel: 440-392-7442 karly eitzman@steris.com

Submission Date: January 8, 2025

K Number: K250061

STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600

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1. Device Name

Trade Name:	Celerity Incubator
Device Class:	Class II
Common/usual Name:	Reader/Incubator
Classification Name:	Biological Sterilization Process Indicator
Classification Number:	21 CFR 880.2800
Product Code:	FRC

2. Predicate Device

K223715 – Celerity Incubator

3. Device Description

4. Indications for Use

Use the Celerity Incubator to incubate and automatically read STERIS Celerity Biological Indicators for Steam and Vaporized Hydrogen Peroxide sterilization at 55°C - 60°C for a fluorescent result.

5. Technological Characteristics Comparison Table

A comparison of technical characteristics between the proposed and predicate devices is summarized in Table 1.

Table 1. Technological Characteristics Comparison Table to predicate device

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Summary of Non-Clinical Performance Testing 6.

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Testing was performed to evaluate performance and demonstrate substantial equivalence to the predicate as summarized in Table 2.

Test	Acceptance Criteria	Result
Software Validation	The software that controls the system was validatedand determined to operate effectively and as designed.	Pass
Qualification Testingwith intendedBiological Indicators	Fluorescent Read meets ≥ 97% alignment with 7-daygrow out per FDA guidance on Reduced IncubationTime for intended Celerity 5 HP Biological Indicatorsand Celerity 20 HP Biological Indicators	Pass
Recognition ofadditional barcodes	Incubator reads barcodes correctly	Pass

Table 2. Performance Testing

7. Conclusion

The Celerity Incubator has met the established performance criteria. Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device (K223715), Class II (21 CFR 880.2800), product code FRC.

Regulation Number and Section

§ 880.2800 Sterilization process indicator.

(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).

Feature	Proposed DeviceCelerity Incubator	Predicate DeviceCelerity Incubator(K223715)	Comparison
Indicationsfor Use	Use the Celerity Incubator toincubate and automaticallyread STERIS Celerity	Use the Celerity Incubator toincubate and automaticallyread STERIS Celerity	Same
Feature	Proposed DeviceCelerity Incubator	Predicate DeviceCelerity Incubator(K223715)	Comparison
	Biological Indicators forSteam and VaporizedHydrogen Peroxidesterilization at 55°C - 60°Cfor a fluorescent result.	Biological Indicators forSteam and VaporizedHydrogen Peroxidesterilization at 55°C - 60°C
Basis ofReadout	Photodiode detectsfluorescence produced byenzymatic activity that resultsfrom viable biologicalindicator organisms.	Photodiode detectsfluorescence produced byenzymatic activity that resultsfrom viable biologicalindicator organisms.	Same
IncubationTemperatureRange	55 - 60 °C	55 - 60 °C	Same
VoltageRange	100-240 VAC with 12 VDCconversion	100-240 VAC with 12 VDCconversion	Same
Test Capacity	8 wells	8 wells	Same
Calibration	Factory calibration - nocalibration by customer	Factory calibration - nocalibration by customer	Same
IncubationTime	5 minutes or 20 minutes,depending on BiologicalIndicator	5 minutes or 20 minutes,depending on the BiologicalIndicator	Same
FluorescenceDetection	UV LEDs are used to excitethe fluorescent moleculeproduced by enzyme cleavageof the fluorogenic substratecontained in the BI's media.The emitted light is detectedby a photodiode.	UV LEDs are used to excitethe fluorescent moleculeproduced by enzyme cleavageof the fluorogenic substratecontained in the BI's media.The emitted light is detectedby a photodiode.	Same
Indication ofResults	Positive - audible alarm,visual LED lights and screenNegative – optional alarm,visual indication with LEDlights and LCD screenUser must acknowledgeresults	Positive – audible alarm,visual LED lights and screenNegative - optional alarm,visual indication with LEDlights and LCD screenUser must acknowledgeresults	Same
SystemOperation	The reader/incubator wellsare arranged in 2 banks of 4wells and preset to 59°C. Theuser scans the barcode on thelabel of an activated BI using	The reader/incubator wellsare arranged in 2 banks of 4wells and preset to 59°C. Theuser scans the barcode on thelabel of an activated BI using	Same
Feature	Proposed DeviceCelerity Incubator	Predicate DeviceCelerity Incubator(K223715)	Comparison
	the system's barcode scannerand places it into an openwell. The system detects thewell the BI was placed intoand begins measurement offluorescence; a blinkingyellow light indicates theincubation is in process andthe read initiated. The	the system's barcode scannerand places it into an openwell. The system detects thewell the BI was placed intoand begins measurement offluorescence; a blinkingyellow light indicates theincubation is in process andthe read initiated. The
	System uses information fromthe barcode to apply theappropriate algorithm to thewell. A "positive" reading isinterpreted as an indication ofa potential sterilization cyclefailure. A "positive" findingis indicated to the user by redlight on the front paneladjacent to the well, by anaudible alarm, and by textdisplayed on the LCD screen.The alarm must be muted bythe operator when a positiveresult is obtained. The LCDscreen provides instructionsfor the user to turn off thealarm for that specific BI.Should another BI become"positive", the alarm willsound again and the aboveactions are repeated.	System uses information fromthe barcode to apply theappropriate algorithm to thewell. A "positive" reading isinterpreted as an indication ofa potential sterilization cyclefailure. A "positive" findingis indicated to the user by redlight on the front paneladjacent to the well, by anaudible alarm, and by textdisplayed on the LCD screen.The alarm must be muted bythe operator when a positiveresult is obtained. The LCDscreen provides instructionsfor the user to turn off thealarm for that specific BI.Should another BI become"positive", the alarm willsound again and the aboveactions are repeated.
	If the result is not positive atthe end of the incubationtime, the result is negative.Negative results are identifiedby a green light on the frontpanel adjacent to the wellwith the "negative" BI and bytext on the LCD. In addition,an optional alarm is availablefor negative results.	If the result is not positive atthe end of the incubationtime, the result is negative.Negative results are identifiedby a green light on the frontpanel adjacent to the wellwith the "negative" BI and bytext on the LCD. In addition,an optional alarm is availablefor negative results.